Gene Expression in the Overactive Bladder in Children

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ClinicalTrials.gov Identifier: NCT02086058

Recruitment Status
: Unknown

Verified December 2015 by University of Aarhus. Recruitment status was: Recruiting

The aim of this study (the hypothesis) is to identify differences in the gene expression profile in the bladder muscle and hereby gain greater knowledge about the muscular mechanisms that cause overactive bladder and daytime urinary incontinence in children older than 5 years. A secondary aim is to examine how this gene expression profile differs from children with a neurogenic overactive bladder and how the gene expression profile changes from childhood till adulthood. Such new knowledge will result in a more precisely targeted and hence effective treatment of overactive bladder.

The results will be obtained by retrieving bladder biopsies from children and adults suffering from an overactive bladder or a neurogenic bladder. These biopsies will undergo molecular analysis and the investigators will compare them with biopises from bladder healthy adults and children.

Up- and down regulation of genes expressed in the bladder [ Time Frame: collection of bladder material and analysis will take approximately 2 years ]

We will evaluate the gene expression (which genes are up- and/or down regulated) in the bladder in healthy children compared to children suffering from an overactive bladder. This gene expression will then be compared to the gene expression in bladder tissue from adults, to evaluate what happens in the bladder from childhood to adulthood.

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Ages Eligible for Study:

5 Years to 80 Years (Child, Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Sampling Method:

Probability Sample

Study Population

We will include 3 groups of patients Group 1: children with an overactive bladder and daytime urinary incontinence Group 2: Children and adults with a neurogenic bladder Group 3: children and adults who have a healthy bladder

Criteria

Inclusion Criteria:

Group 1: Group 1 (non-neurogenic bladder/overactive bladder):

age 5-14 years of age

patients must have filled out 48-hour bladder diaries

a minimum of 4 micturitions per day (assessed from the bladder diaries)

functional daytime urinary incontinence

overactive bladder as defined by urgency

no signs of neurogenic bladder dysfunction on invasive urodynamics

a non-remarkable clinical examination

normal BMI (between 3-97 percentile)

informed oral and written consent from the child and both parents/legal guardian. In the informed consent the parents /legal guardian have given permission to the authorities (The Danish Ethical Committee), so that they may get information about the child during monitoring and quality inspection visits.

no effect of prior treatment of at least 6 months urotherapy

no effect of prior treatment of at least 3 months of anticholinergic treatment

planned to undergo a cystoscopy under anesthesia

Group 2:

5-14 years of age or >18 years old

diagnosed with a neurogenic bladder (i.e. caused by myelomeningocele)

informed oral and written consent from the child and both parents/legal guardian. In the informed consent the parents /legal guardian have given permission to the authorities (The Danish Ethical Committee), so that they may get information about the child during monitoring and quality inspection visits.

a medical history, clinical or biochemical tests that indicate that the child suffers from any type of disease (such as acute urinary infection or diabetes) or condition (such as pregnancy) influencing the child´s possibility of participating in the study, or that may effect the study parameters that are under examination.

ongoing fecal problems such as fecal incontinence or constipation

prior surgery involving the bladder

ongoing urinary tract infections

ongoing treatment with any type of medicine that may effect the study parameters that are under examination

Group 2:

a medical history, clinical or biochemical tests that indicate that the child suffers from any type of diseases (such as diabetes) or conditions (such as pregnancy) influencing the child´s possibility of participating in the study, or that may affect the study parameters that are under examination.

ongoing treatment with any type of medicine that may affect the study parameters that are under examination

urinary incontinence and an overactive bladder with urinary incontinence

a medical history, clinical or biochemical tests that indicate that the patient suffers from any type of disease (such as acute urinary tract infection or diabetes) or condition (such as pregnancy) influencing the patient´s possibility of participating in the study, or that may effect the study parameters that are under examination.

any type of bladder disease or any disease secondary affecting the bladder

prior bladder surgery

ongoing urinary tract infection

ongoing treatment with any type of medicine that may effect the study parameters that are under examination.